In 1997, the FDA rules governing pharmaceutical advertising changed, and THAT changed how consumers learned about prescription medications. We see the result today, with drug advertising breaking into our favorite television dramas and sitcoms on a (too) regular basis.
Before doctors can prescribe the products and before pharmaceutical companies can advertise them, drugs must go through years of “clinical trials.” The trials are as close as patients can get to an assurance that the drug will work as prescribed and side effects will be known and communicated. Two College of Pharmacy professors recently added to the body of knowledge on drugs in clinical trials by publishing a comparison of investigational anticoagulants that are coming on the market.
Timothy Burkart, Pharm.D., and Paluri Sai Shantanu Rao, Ph.D., teamed up this academic year to publish an article in the international journal Blood Reviews, entitled ­­­­­­­­­­­­ “Advances in oral anticoagulation therapy – What’s in the pipeline?” In layman’s terms, the article compares three investigational drugs: Darexaban, Betrixaban and Nokxaban. All have been created to prevent life-threatening blood coagulation events, like blood clots and VTE’s (venous thromboembolisms). These blood coagulation events affect approximately 900,000 people each year. Hospitalized patients, especially those recovering from hip and knee replacements, are especially at risk. Blood clots in the legs or lungs are responsible for hundreds of thousands of deaths annually.
But why would pharmaceutical companies spend money on developing new anticoagulants, when there are already several on the market that are effective?
“These new drugs are designed to be more patient friendly,” said Burkart. “We feel there are fewer problems metabolizing the medications and fewer food and drug interactions.” In addition, he added, that the drugs currently under trial would not require patients to have blood drawn and tested regularly, as they need to do when taking Coumadin.
The team wrote the article after an extensive literature review. Rao was even able to unearth some of the original trials.
“I saw very little literature on these particular drugs,” Rao added, “and no comparisons. I think our study has really filled a gap in the knowledge.”
Blood Reviews published the article online on Feb. 3, 2017 and it will also be carried in a future print version of the publication. Although their research is intended for the pharmacy and medical community, both Burkart and Rao agree that consumers need accurate information as well.Reliable Information
“Patients always want to know ‘What’s next?’ and ‘What’s better?’” said Burkart. “They’ll hear about a drug under development and start asking questions. What they need to realize is that no drug makes it to market without the three-part clinical trial. In pharmaceuticals, that timeline is years, not months.”
Burkart feels that drug advertising is a “mixed bag.” He thinks it’s good to have informed consumers, but doesn’t agree with how the consumer is being informed. He feels that when he talks with patients, most of them are either uninformed or misinformed.
Instructor Suzanne Surowiec, Pharm.D., assigns her first-year pharmacy students a report on a drug advertised on television. “They need to watch the commercial and do a presentation on it for the class. Would they recommend the drug or not?” Rao explained.
The two College of Pharmacy professors are a good team. Rao has a background in pharmacy research, while Burkart is a practitioner. They agree that they both really like investigating and comparing new drugs. Will this enthusiasm lead to future articles?
“We think we’re going to keep doing review articles for publication,” said Burkart. “The next condition we’ll investigate will likely be drugs for Alzheimer’s.”
“An effective drug for treating Alzheimer’s is something we all want so badly,” added Rao, “but drugs in this category have a lot of difficulty making it successfully through trials.”
Although pharmacy students weren’t directly involved in research for the article, the College of Pharmacy does offer an elective in anticoagulants where the class regularly meets with and monitors a patient who is taking a medication in this category.
What’s the best way to learn about a drug that you’re taking or planning to take? Both Burkart and Rao encourage people to ask their pharmacist. They advise building a relationship with a local store and the pharmacists who practice there.
The two pharmacy professors agree. “Pharmacists are an integral part of your health care team.”

Pharmacy Profs Join Forces to ‘Double Team’ New Drugs

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